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Comparing KIM to TVT Exact Sling

NCT04985799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2024-08-06

Study results available
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Summary

To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling.

Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with objective evidence of SUI planning surgery for stress urinary incontinence.

Procedures (methods): Patients will be randomized to receive either the Gynecare TVT Exact sling or the retropubic Neomedic KIM sling. Patients will be followed for 1 year postoperatively.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Gynecare TVT Exact Continence System

Participants will have placement of Gynecare TVT Exact sling.

DEVICE

Neomedic KIM (Knotless Incontinence Mesh)

Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Jennifer Wu, MD, MPH · University of North Carolina, Chapel Hill

  • Christina Kunycky, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2023-05-31
Completion
2024-06-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985799 on ClinicalTrials.gov